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A Multi-Center Group to Study Acute Liver Failure in Children

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ClinicalTrials.gov Identifier: NCT00986648
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : January 12, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Pittsburgh

Brief Summary:
The PALF study group began with 20 sites and now continues with 12 sites (11 in the United States and 1 in Canada) in the new funding period. The primary objective of the Pediatric Acute Liver Failure (PALF) study is to collect, maintain, analyze, and report clinical, epidemiological, and outcome data in children with ALF, including information derived from biospecimens.

Condition or disease
Acute Liver Failure Hepatic Encephalopathy

Detailed Description:
The PALF study group will collect clinical, epidemiological and outcome data on children with ALF. This information will be used to develop methods to predict whether a child will recover from the illness without the need for a liver transplant or other life-saving procedure. We believe the methods to predict survival will vary with different patient age groups, but that diagnosis, multi-system organ failure, degree of encephalopathy and level of coagulopathy will be important regardless of patient age. Biological samples, such as blood and liver tissue, will provide opportunities to identify subgroups of patients who have unique treatment requirements and outcomes. In addition, we hope to identify unrecognized mechanisms of liver injury resulting in ALF in children. Eligible study participants will be invited to participate in neurocognitive testing. Since patients that develop acute liver failure experience varying levels of hepatic encephalopathy and cerebral edema, we suspect that there may be residual sub-clinical neurological injury that compromises long-term neurocognitive function. Detailed neurocognitive testing has never been performed in a cohort of children that survive acute liver failure and this study seeks to close that information gap by defining the spectrum of neurocognitive outcomes in this population.

Study Type : Observational
Actual Enrollment : 158 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Center Group to Study Acute Liver Failure in Children
Study Start Date : January 2000
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine





Biospecimen Retention:   Samples With DNA
whole blood, serum, tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children between birth and age 18 years who present with acute liver failure.
Criteria

Inclusion Criteria:

  • Written informed consent/assent
  • Birth through 17 years of age
  • Biochemical evidence of acute liver injury
  • Coagulopathy not corrected by vitamin K (or other intervention intended to correct coagulopathy)

    • The presence of encephalopathy (ENC) is required if the INR is at least 1.5 and less than 2.0
    • If INR is at least 2.0, the presence of ENC is not required

Exclusion Criteria:

  • Known chronic underlying liver disease
  • Multi-organ system failure following heart surgery or ECMO
  • Solid organ or bone marrow transplantation
  • Acute trauma
  • Previously enrolled in the PALF Cohort Study
  • Other severe illness, condition, or other reason in the opinion of the investigator that would make the patient unsuitable for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986648


  Show 20 Study Locations
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Robert H Squires, MD Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00986648     History of Changes
Other Study ID Numbers: 1U01DK072146-01 ( U.S. NIH Grant/Contract )
U01DK072146 ( U.S. NIH Grant/Contract )
2U01DK072146-06 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by University of Pittsburgh:
acute liver failure
hepatic encephalopathy
acetaminophen toxicity

Additional relevant MeSH terms:
Brain Diseases
Liver Failure
Hepatic Encephalopathy
Liver Failure, Acute
Central Nervous System Diseases
Nervous System Diseases
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases